F.D.A. Advisers Weigh Allowing First U.S. Over-the-Counter Birth Control Pill

And Dr. Karen Murry, deputy director of the agency’s Office of Nonprescription Drugs, pushed back on a much-quoted figure that over 100 countries have over-the-counter pills. She said that pharmacists dispense such pills in most of those countries, so Americans’ experience might be different. Here, she said, “if this product is approved, people might get it in a pharmacy, but they also might get it in a gas station or a big box store with no health care professionals around.”

Presentations supporting the company made a very different case.

“Despite availability of a variety of contraceptive methods, nearly half of the pregnancies are unintended every year,” Dr. Carolyn Westhoff, an obstetrician-gynecologist at Columbia University’s Mailman School of Public Health, testified. She noted that other over-the-counter methods, such as condoms, were less effective than the pill and added, “We need more effective methods to be available without a prescription.”

Dr. Westhoff suggested that for most women, there is no advantage to a doctor prescribing the pills because doctors don’t typically monitor patient adherence and often only see such patients once a year. She said it was especially important to make the pill available to adolescents because “these youngest women faced most significant barriers to accessing the more effective methods.”

Other speakers, including some who spoke during the public comment session, emphasized that the product would also be helpful for women in low-income, rural and marginalized communities who didn’t have insurance or who found it difficult to see a doctor for a prescription because of the time, transportation or child care costs involved.

Dr. Pamela Goodwin, a breast cancer oncologist at Sinai Health System in Toronto, testified that very few breast cancer patients would be at risk, because their doctors would advise them against using it. The company’s study found that 97 percent of breast cancer patients correctly opted not to take the pill.

The study reported that participants had taken the pill on 92.5 percent of the days they were supposed to take it, Dr. Stephanie Sober, the U.S. medical liaison for the company. She said that nearly 85 percent of participants had taken a pill on at least 85 percent of the days. Most participants who missed a pill reported that they had followed the label’s directions to take mitigating steps such as abstaining from sex or using a condom, Dr. Sober said, adding that among 955 participants, only six women had become pregnant while using Opill.

“Let’s face it — the instructions for Opill use are extremely simple: Take one pill, at the same time every day,” said Dr. Anna Glasier, a British reproductive health expert who testified for the company. “The vast majority of women did just that. And if they made a mistake, most took the appropriate mitigating action. And let’s remember that the women who did miss pills often did so because they could only get a supply from the site where they had enrolled, while in the real world situation, they could have bought a pill from any drugstore.”

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